FDA WARNING_LETTER - HTO Nevada, Inc. dba Kirkman - August 22, 2025

FDA WARNING_LETTER for HTO Nevada, Inc. dba Kirkman on August 22, 2025. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for HTO Nevada, Inc. dba Kirkman on August 22, 2025. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 CFR 211.22(b)

FD&C Act 501(a)(2)(B)

21 CFR 211.166(a)

21 CFR 211

21 CFR 210

21 CFR 211.22(a)

21 CFR 211.22

21 CFR 211.180(e)

21 CFR 211.34

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Record Information

Company

HTO Nevada, Inc. dba Kirkman

Inspection Date

August 22, 2025

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 1e6d4076-5016-400e-91d0-bc71a2fb5680

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